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Necitumumab, an epidermal growth factor receptor (EGFR) antagonist, combined with two forms of chemotherapy, has been approved as a first-line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). the Food and Drug Administration announced on Nov. 24.
Necitumumab is a “monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous NSCLC tumors,” the FDA statement said. The statement points put that necitumumab “was not found to be an effective treatment” in patients with nonsquamous NSCLC.
Eli Lilly will market necitumumab as Portrazza. It is administered as an intravenous infusion over 60 minutes on days 1 and 8 of each 3-week cycle.
“Today’s approval provides certain patients with squamous cell lung cancer a new option that may extend survival,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research, said in the statement.
Necitumumab was evaluated in multicenter, randomized, open-label study of 1,093 people with advanced squamous NSCLC, treated with gemcitabine and cisplatin with or without necitumumab. Median overall survival, the primary endpoint, was 11.5 months in the necitumumab-treated arm vs. 9.9 months among controls, a 1.6 month difference that was statistically significant.
At a July meeting of the FDA’s Oncologic Drugs Advisory Committee, 11 of the 12 panelists agreed that the efficacy and safety results of this study supported a “positive benefit risk assessment” of necitumumab combined with gemcitabine and cisplatin for this group of patients – despite a modest effect on overall survival, a very small but statistically significant effect on progression-free survival, and some safety concerns, the main question they were asked by the FDA to discuss.
Rash and hypomagnesemia are the most common adverse events associated with necitumumab, according to the FDA.
The prescribing information includes a boxed warning regarding the risk of cardiopulmonary arrest and hypomagnesemia associated with treatment, and points out that 83% of the patients treated with necitumumab, gemcitabine, and cisplatin developed hypomagnesemia, which was severe in 20%; and that the rate of cardiopulmonary arrest and/or sudden death occurred in 3% of those on the combination.
Serious adverse events associated with necitumumab should be reported to the FDA’s MedWatch program.
Necitumumab, an epidermal growth factor receptor (EGFR) antagonist, combined with two forms of chemotherapy, has been approved as a first-line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). the Food and Drug Administration announced on Nov. 24.
Necitumumab is a “monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous NSCLC tumors,” the FDA statement said. The statement points put that necitumumab “was not found to be an effective treatment” in patients with nonsquamous NSCLC.
Eli Lilly will market necitumumab as Portrazza. It is administered as an intravenous infusion over 60 minutes on days 1 and 8 of each 3-week cycle.
“Today’s approval provides certain patients with squamous cell lung cancer a new option that may extend survival,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research, said in the statement.
Necitumumab was evaluated in multicenter, randomized, open-label study of 1,093 people with advanced squamous NSCLC, treated with gemcitabine and cisplatin with or without necitumumab. Median overall survival, the primary endpoint, was 11.5 months in the necitumumab-treated arm vs. 9.9 months among controls, a 1.6 month difference that was statistically significant.
At a July meeting of the FDA’s Oncologic Drugs Advisory Committee, 11 of the 12 panelists agreed that the efficacy and safety results of this study supported a “positive benefit risk assessment” of necitumumab combined with gemcitabine and cisplatin for this group of patients – despite a modest effect on overall survival, a very small but statistically significant effect on progression-free survival, and some safety concerns, the main question they were asked by the FDA to discuss.
Rash and hypomagnesemia are the most common adverse events associated with necitumumab, according to the FDA.
The prescribing information includes a boxed warning regarding the risk of cardiopulmonary arrest and hypomagnesemia associated with treatment, and points out that 83% of the patients treated with necitumumab, gemcitabine, and cisplatin developed hypomagnesemia, which was severe in 20%; and that the rate of cardiopulmonary arrest and/or sudden death occurred in 3% of those on the combination.
Serious adverse events associated with necitumumab should be reported to the FDA’s MedWatch program.
Necitumumab, an epidermal growth factor receptor (EGFR) antagonist, combined with two forms of chemotherapy, has been approved as a first-line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). the Food and Drug Administration announced on Nov. 24.
Necitumumab is a “monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous NSCLC tumors,” the FDA statement said. The statement points put that necitumumab “was not found to be an effective treatment” in patients with nonsquamous NSCLC.
Eli Lilly will market necitumumab as Portrazza. It is administered as an intravenous infusion over 60 minutes on days 1 and 8 of each 3-week cycle.
“Today’s approval provides certain patients with squamous cell lung cancer a new option that may extend survival,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research, said in the statement.
Necitumumab was evaluated in multicenter, randomized, open-label study of 1,093 people with advanced squamous NSCLC, treated with gemcitabine and cisplatin with or without necitumumab. Median overall survival, the primary endpoint, was 11.5 months in the necitumumab-treated arm vs. 9.9 months among controls, a 1.6 month difference that was statistically significant.
At a July meeting of the FDA’s Oncologic Drugs Advisory Committee, 11 of the 12 panelists agreed that the efficacy and safety results of this study supported a “positive benefit risk assessment” of necitumumab combined with gemcitabine and cisplatin for this group of patients – despite a modest effect on overall survival, a very small but statistically significant effect on progression-free survival, and some safety concerns, the main question they were asked by the FDA to discuss.
Rash and hypomagnesemia are the most common adverse events associated with necitumumab, according to the FDA.
The prescribing information includes a boxed warning regarding the risk of cardiopulmonary arrest and hypomagnesemia associated with treatment, and points out that 83% of the patients treated with necitumumab, gemcitabine, and cisplatin developed hypomagnesemia, which was severe in 20%; and that the rate of cardiopulmonary arrest and/or sudden death occurred in 3% of those on the combination.
Serious adverse events associated with necitumumab should be reported to the FDA’s MedWatch program.
